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  4. Common Labeling Deficiencies and Tips for Generic Drug Applications - 05/07/2021 - 05/07/2021
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Webcast

Event Title
Common Labeling Deficiencies and Tips for Generic Drug Applications
May 7, 2021


Date:
May 7, 2021
Time:
1:00 PM - 2:00 PM ET


 

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Visit the CDER Small Business and Industry Assistance Webpage

FDA will discuss the most common labeling mistakes found in Abbreviated New Drug Applications (ANDAs) and how to avoid them and other labeling tips. FDA will also provide answers to common labeling questions asked by generic drug applicants.

Topics

  • Frequently asked labeling questions from ANDA applicants
  • Most common labeling deficiencies and how to avoid them

Audience

  • Generic drug industry stakeholders including current and potential applicants who are interested in submitting an application for generic drug development.

FDA Speakers

  • Charlene Peterson, PharmD, Label Reviewer
  • Younsook Kim, PhD, PharmD, Labeling Reviewer/Special Assistant
  • CDR Esther Chuh, PharmD, BCGP, Team Leader
  • Marshall Florence, PharmD, Team Leader

Division of Label Review (DLR) | Office of Generic Drugs (OGD) | CDER | FDA

FDA Resources

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